Pelvic Mesh Lawsuit Update

The FDA has ordered a halt to the sale of pelvic mesh devices in the United States as a result of a multistate suit against Boston Scientific. The complaint alleged that Boston Scientific failed to disclose the full range of complications associated with the implant. While the company has agreed to make numerous changes to its training, marketing, and clinical studies, the lawsuits continue. The company has been hit with more than $330 million in litigation-related charges.

A major trial has been scheduled in California for the upcoming case against the Johnson & Johnson group of companies.

The plaintiffs claim that the company knew about the serious risks of the transvaginal mesh implant, but failed to warn doctors and consumers about those risks. The first trial for this litigation was deadlocked in September 2018, but a retrial is set for February. The manufacturer has agreed to settle the claims of women who experienced painful and permanent complications from the implants.

In another case, an Australian medical board approved a $16 million settlement with Coloplast. This is about $40k per claimant. In 2015, Medtronic, one of the biggest medical device companies, agreed to buy Covidien Plc for a record $22 billion. In a June 2015 SEC filing, the company disclosed that its Covidien unit was involved in over 11,500 mesh lawsuits. As a result of these lawsuits, Medtronic set aside $180 million to resolve the claims.

The first trial for the J& J device involved over 700 patients in Australia.

In that case, J& J admitted to not testing the product adequately and selling it without warning surgeons and patients about the risks. The mesh is complicated and only for experienced surgeons. Since the settlement, the Therapeutic Goods Administration has banned the use of the implant in Australia and New Zealand. The lawsuits are a massive effort to stop the product’s sales and to stop the suffering of its users.

In an attempt to stop the spread of pelvic mesh, the U.S. Food and Drug Administration (FDA) has banned the sale of surgical mesh devices. In its order, Boston Scientific failed to prove that its products were safe, effective, and effective for the intended purposes. However, the FDA also found that its failure to test the implant had led to the deaths of more than 700 patients. As a result, the U.S. government has ordered a halt to the sale of the products.

Despite these legal actions, a settlement has still not been reached between the companies.

The FDA ruled in favor of the plaintiffs in a case against C.R. Bard in April 2019. After the U.S. Food and Drug Administration banned the use of the mesh in Australia, the company settled the lawsuits and has not sold its products in the country. Although this is a setback for the patients, the FDA’s decision has not prevented the lawsuits from being filed.

A new Australian court ruling has found that a woman’s pain was caused by a defective pelvic mesh implant in her pelvic area. Fortunately, the case also helped her receive a total of $35 million in compensation. While the amount of compensation awarded is not the same in every country, it is more than enough to show that the plaintiffs deserve the compensation that they received. They were wrong to blame a surgeon for this wrongful outcome.

In a recent SEC filing, Medtronic confirmed that it had settled the pelvic mesh lawsuits with Coloplast.

The settlement amounts to $16 million and works out to approximately $40k per claimant. The settlement was made after the SEC filing revealed that the company had failed to properly test its kits and warned doctors of the risks associated with the mesh. In June 2015, the SEC also found that the company failed to test the TVT-Secure implant and its related mesh kit. As a result, the company had to pay over $180 million for the product.

The lawsuits filed against Coloplast A/S and its subsidiary, Ethicon, were the first to be resolved. On Sept. 12, 2018, the FDA ordered the sale of these devices after finding that Boston Scientific and Coloplast A/S failed to provide reasonable assurance of safety and effectiveness. The ruling has left women with permanent nerve damage and severe pain. They have already lost their cases in court. While there are still many unresolved claims, the FDA’s ruling has led to several changes to the products.

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